Overview
Title
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expedited Programs for Serious Conditions-Drugs and Biologics
Agencies
ELI5 AI
The FDA wants to make sure new medicines for serious illnesses are made faster and is asking for permission from another office to gather information about this. They also want to know what people think by March 22, 2021, but nobody has sent in comments yet.
Summary AI
The Food and Drug Administration (FDA) has submitted a proposed information collection to the Office of Management and Budget (OMB) for review. This collection involves FDA's expedited programs for serious and life-threatening conditions, such as fast track and breakthrough therapy designations, which are designed to speed up the development and marketing of new drugs and biologics. The FDA has issued guidance for sponsors developing these therapies, and is accepting public comments until March 22, 2021. The agency estimates significant effort will be required from participants to prepare necessary documentation, with varying hours needed depending on the type of request.
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Keywords AI
Sources
AnalysisAI
The document under review is an important regulatory notice from the Food and Drug Administration (FDA) concerning expedited programs for developing drugs and biologics intended to treat serious and life-threatening conditions. These programs, such as the fast track and breakthrough therapy designations, are critical because they aim to accelerate the availability of new treatments to patients who need them the most.
General Summary of the Document
The FDA has submitted a request to the Office of Management and Budget (OMB) for review and clearance of a proposed collection of information under the Paperwork Reduction Act of 1995. This proposal is linked to the guidance provided for industry stakeholders engaged in developing therapies for serious conditions. The document outlines the FDA's expedited programs, detailing the processes and prerequisites for obtaining different designations like fast track, breakthrough therapy, accelerated approval, and priority review.
Currently, the FDA is inviting public comments, with a submission deadline of March 22, 2021. The document also provides estimates of the effort required from stakeholders in terms of time investment to prepare documentation for the requests under these expedited programs.
Significant Issues or Concerns
One of the notable concerns in the document is the use of technical jargon without offering clear and accessible definitions. Terms like "fast track designation" and "regenerative advanced therapies" may not be easily understood by those unfamiliar with FDA processes. This could potentially alienate a portion of the interested but non-expert audience.
Moreover, the document estimates an average of 30 to 100 hours for preparing various designation requests but does not provide detailed justification for these estimates. This lack of clarity may lead to questions regarding the accuracy and fairness of the stated burden.
The document also reports that no public comments were received during a prior notice period. This absence of feedback might suggest insufficient public engagement or awareness, which could undermine the effectiveness of the review process.
Furthermore, while the document mentions an increase in estimated burden hours by 389 responses and 35,325 hours, it does not clarify why this increase has occurred. This lack of explanation could lead to misunderstandings about the reasonableness of the estimation changes.
Impact on the Public and Specific Stakeholders
The potential impact of this document on the public is both direct and indirect. For patients and healthcare providers, the expedited development of new therapies holds promise for improved health outcomes through quicker access to crucial medicines. However, the complexity of the document's language might limit broader public understanding of how these expedited programs function and their benefits.
For industry stakeholders, especially pharmaceutical companies and sponsors developing new therapies, the document outlines the procedural requirements they must fulfill to gain these expedited designations. While this guidance supports efficient regulatory compliance, concerns about the time and resources required could influence the willingness or ability of smaller entities to participate, possibly skewing opportunities toward larger, well-resourced companies.
In conclusion, while the intentions behind the FDA’s expedited programs are commendable, the document could improve in facilitating broader understanding and engagement by offering clearer explanations, justifying burden estimates, and fostering increased public participation in the commenting process. Addressing these areas will enhance transparency and support a more inclusive conversation about advancing healthcare innovations.
Issues
• The document uses technical terms such as 'fast track designation,' 'breakthrough therapy designation,' and 'regenerative advanced therapies' without providing clear explanations, which may be difficult for readers unfamiliar with these terms.
• The document assumes that an average of 30 to 100 hours is needed for different types of designation requests, but it does not provide a justification or breakdown for these estimates, which could raise concerns about their accuracy.
• The document mentions 'no comments were received' during the public comment period, which might indicate a lack of public engagement or awareness of this process.
• While the document mentions an increase in burden estimates, it does not elaborate on the reasons behind the increase by 389 responses and 35,325 hours, leaving room for ambiguity.
• The document provides a detailed process for submitting requests for expedited programs but lacks a summary or simplified guide for quick understanding.
• There is no information about potential costs to the sponsors or applicants resulting from the additional burden hours, which could indicate oversight of financial implications.